Suture devices particularly useful in endoscopic surgery

ABSTRACT

Suture devices, primarily for use in endoscopic surgery, include a suture needle having a length of suture material attached thereto with a contractible loop or passage at the proximal end of the suture material to allow the suture needle to be passed therethrough, the loop or passage contracting to clamp or grip the suture material to function similar to a conventional tied suture knot.

This is a divisional application of application Ser. No. 07/534,495,filed June 7, 1990, U.S. Pat. No. 4,981,149, which is a divisionalapplication of application Ser. No. 07/353,913 filed May 16, 1989 nowU.S. Pat. No. 4,932,962.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to surgical suture devices and, moreparticularly, to suture devices made of bioabsorbable materialsparticularly useful in endoscopic surgery and methods of suturing usingsuch suture devices.

2. Discussion of the Prior Art

Suturing of bodily tissue is a time consuming part of most surgicalprocedures including both open surgery and endoscopic or closed surgery.By open surgery is meant surgery wherein the surgeon gains access to thesurgical site via a relatively large incision, and by endoscopic surgeryis meant surgery wherein the surgeon gains access to the surgical sitevia one or more portals through which endoscopes are introduced to viewthe surgical site and through which instruments, such as forceps,cutters, applicators and the like, are introduced to the surgical site.There are many common endoscopic surgical procedures, includingarthroscopy, laparascopy (pelviscopy), gastroentroscopy andlaryngobronchoscopy, for example. In the past, suturing has beenaccomplished with the use of a sharp metal suture needle attached to theend of a length of suture material, the suture needle being caused topenetrate and pass through the tissue pulling the suture materialthrough the tissue. Once the suture material has been pulled through thetissue, the surgeon ties a knot in the suture material, the knottingprocedure allowing the surgeon to adjust the tension on the suturematerial to accommodate the particular tissue being sutured and controlapproximation, occlusion, attachment or other conditions of the tissue.The ability to control tension is extremely important to the surgeonregardless of the type of surgical procedure being performed; however,knotting of the suture material is time consuming and tedious work,particularly in microsurgery and endoscopic surgery. That is, inmicrosurgery suturing is necessarily time consuming due to the smallsize of the suture needle and the suture material and the concomitantdifficult manipulation required to pass the suture needle through thetissue and to tie a knot in the suture material. With respect toendoscopic surgery, suturing and tying knots represents an even moretime consuming procedure due to the difficult maneuvers required.Accordingly, while endoscopic surgery would be preferred for mostprocedures, the advantages are often outweighed by the disadvantagescaused by the length of time required to complete the endoscopicsurgical procedure, which time is greatly extended due to the timerequired for suturing. Another disadvantage of suturing with a metalsuture needle and suture material during endoscopic surgery is that thesuture needle is difficult to hold and manipulate and can be easilydropped. Should the suture needle be dropped, open surgery with itsattendant disadvantages must be performed to find and remove the needle.

There have been many attempts to provide devices to take the place ofconventional suturing with a suture needle and a length of suturematerial; however, such prior art devices have essentially been staples,clips, clamps or other fasteners not providing the adjustable tensionobtained by the surgeon while knotting a length of suture material. U.S.Pat. Nos. 3,827,277 to Weston, 4,060,089 to Noiles, 4,490,326 to Beroffet al, 4,513,746 to Aranyi et al, 4,532,926 to O'Holla, 4,548,202 toDuncan, 4,573,469 to Golden, No. 4,590,937 to Deniega, 4,595,007 toMeride, 4,602,634 to Barkley, 4,646,741 to Smith, 4,671,280 to Dorbandet al, 4,719,917 to Barrows et al and 4,741,337 to Smith et al arerepresentative of such prior art devices for use in place ofconventional suturing. Many of these prior art devices are made ofbioabsorbable materials such that the devices are absorbed over timeinto the bodily tissue and do not have to be removed after the bodilytissue has healed.

There exist many compositions useful as bioabsorbable materials, asrepresented by the above patents and by U.S. Pat. Nos. 3,739,773 toSchmitt et al, 3,797,499 to Schneider, 4,141,087 to Shalaby et al,4,300,565, 4,523,591 to Kaplan et al and 4,649,921 to Koelmel et alwhich discuss characteristics of various bioabsorbable materials andmedical devices desirably manufactured of such materials, such medicaldevices being of a type designed to be engaged in, embedded in orotherwise attached to various types of bodily tissue, such as bone,muscle, organs, skin and other soft tissue, to remain in place in thetissue until the device is absorbed into the body.

U.S. Pat. No. 3,570,497 to Lemole discloses a suture device formed of aneedle with a piercing point extending from a latch cord carryingnotches designed to pass through a latch collar, the latch cord beingresilient to be curved upon itself to form a suture stitch withoutrequiring tying of a knot; however, the latching function does notprovide the same feel and tension control as knotting a length of suturematerial. U.S. Pat. No. 4,548,202 to Duncan uses similar structure in atissue fastener device in that serrations or angled barbs are providedon spaced legs passing through tissue to be engaged by an aperturedreceiver or a flexible filament mesh. U.S. Pat. No. 3,123,077 to Alcamodiscloses a surgical suture carrying raised projections or depressionsor teeth such as barbs or spicules to snag or penetrate tissue toeffectively hold a sewed incision or wound.

Endoscopic surgery is preferred over open surgery due to the greatlyreduced trauma and wound healing time for the patient and due toconcomitant cost savings associated with shorter hospital stays andperforming surgery without general anesthesia and in non-hospital orout-patient surgery sites. Accordingly, there has been much effort spentto develop techniques for facilitating the suturing normally performedby use of a metal suture needle and a length of suture material.Alternative techniques proposed have included electrical coagulation,mechanical devices such as clips, clamps and staples, and lasers;however, no well accepted alternative has yet been found in thatsuturing and tying are essential and vital parts of most surgicalprocedures. That is, to date the proposed alternatives have haddisadvantages, including increased risk to the patient, while notproviding the surgeon with the advantages of suturing and tying and notbeing useful in a wide range of procedures to allow expansion of theareas in which endoscopic surgery can be effectively performed. Thus,there is a great need for suture devices, particularly useful inendoscopic surgery, that allow surgeons to suture and tie knots in amanner with which they are familiar without undue concern as to the lossof the suture needle and further for suture devices that allowcontrolled approximation of tissue and tying to produce controlledtension.

SUMMARY OF THE INVENTION

Accordingly, it is a primary object of the present invention to providesuture devices particulary useful in endoscopic surgery overcoming theabove mentioned disadvantages of the prior art.

Another object of the present invention is to construct a suture needleof the type attached to a length of suture material to pull the suturematerial through tissue to be sutured of a bioabsorbable material suchthat, should the suture needle be dropped or lost during endoscopicsurgery, open surgery is not required to remove the needle.

A further object of the present invention is to facilitate attachment ofa length of suture material to a suture needle made of bioabsorbablematerial by using the plastic characteristics of the bioabsorbablematerial.

An additional object of the present invention is to form a loop orpassage in the proximal portion of a length of suture material in amanner such that the loop or passage tightly grips the length of suturematerial after a suture needle attached to the distal end of the lengthof suture material has passed through the loop or passage to pull thelength of suture material therethrough forming an adjustably controlledknot after suturing.

The present invention has another object in that a suture needle isformed of bioabsorbable material with a rigid distal portion having asharp tip and semi-rigid or flexible proximal and/or central portions tofacilitate manipulation of the suture needle for various procedures.

Yet an additional object of the present invention is to provide a sutureneedle that can be used to position a length of suture material intissue to be sutured and can be left embedded in the tissue byconstructing the suture needle of bioabsorbable material.

The present invention is generally characterized in a suture device forjoining bodily tissue formed of a length of suture material and a sutureneedle having a distal end with a sharp penetrating point and a proximalend with means for engaging the length of suture material such that thesuture needle can penetrate tissue to be sutured to pull the length ofsuture material through the tissue to leave the length of suturematerial in the tissue, the suture needle being made of bioabsorbablematerial whereby said suture needle can be absorbed by the body.

Some of the advantages of the present invention over the prior art arethat open surgery is not required should a suture needle be dropped orlost during endoscopic surgery, suture needles can be made withcontrolled rigidity to facilitate specific surgical procedures,attachment of the suture needle to a length of suture material isfacilitated by the plastic characteristics of the bioabsorbablematerial, and a knotting or suture tying function is provided by passinga suture needle through a contractible passage or loop carried at aproximal portion of a length of suture material attached to the sutureneedle.

Other objects and advantages of the present invention will becomeapparent from the following description of the preferred embodimentstaken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a suture device formed of a suture needle and alength of suture material in accordance with the present invention.

FIG. 2 is a broken sectional view of the suture device of FIG. 1.

FIG. 3 is an exploded perspective view showing formation of the suturedevice of FIG. 1.

FIGS. 4 and 5 are broken sectional views of modifications of the suturedevice of FIG. 1.

FIG. 6 is an exploded side view of another embodiment of a suture deviceaccording to the present invention.

FIG. 7 is a side view of the assembled suture device of FIG. 6.

FIG. 8 is a perspective view of another embodiment of a suture deviceaccording to the present invention.

FIG. 9 is a broken side view illustrating use of the suture device ofFIG. 8.

FIG. 10 is a perspective view of another embodiment of a suture deviceaccording to the present invention.

FIG. 11 is a section taken along line 11--11 of FIG. 10.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

A suture device 30 according to the present invention is illustrated inFIGS. 1 and 2 and is formed of a suture needle 32 having a curved,C-configuration as shown in FIG. 1 or straight or slightly curved shapesas shown in FIGS. 4 and 5 at 32a and 32b, respectively, or any otherconventional suture needle shape, the suture device 30 also including alength of suture material 34 attached or secured to a proximal end 36 ofthe suture needle. By suture needle is meant a needle specificallydesigned for penetrating bodily tissue and pulling through the tissue alength of suture material to approximate edges of tissue, such as resultfrom an incision or wound, to permit the tissue to join together duringhealing. Suture needles are severed from the suture material once thesuturing procedure of placing sufficient stitches or loops of suturematerial in the tissue is completed and are commonly made of metal. Thatis, suture needles are not designed to remain in the tissue but ratherserve only the purpose of penetrating the tissue to position the suturematerial therein. After the suturing procedure and severing of thesuture needles, the suture needles are conventionally sterilized forreuse or, more commonly, discarded.

In accordance with the present invention, the suture needle 32 is madeof bioabsorbable material even though suture needles are not intended toremain in the tissue as are medical devices commonly made ofbioabsorbable material. The bioabsorbable material is rigid at a sharppoint 38 on a distal portion of the suture needle to easily penetratetissue to be sutured and can be rigid throughout the length thereof, ora proximal portion adjacent proximal end 36 can also be rigid while acentral portion extending between the distal and proximal portions canbe flexible to facilitate particular suturing maneuvers. In addition,both the central and proximal portions can be flexible for use in othersuturing maneuvers, it being appreciated that the ability to makecertain portions of the needle flexible provides many advantages inendoscopic surgery due to the limitations concomitant with suturing in aconfined area with the use of a needle holder. The length of suturematerial 34 is preferably also made of bioabsorbable material but couldbe made of conventional materials, the suture material being flexible toconform to the desired suturing configuration in the tissue. For someuses, it is preferable for the suture material to be made of a flexible,elastic (stretchable) bioabsorbable material. The suture material 34preferably has a diameter the same as the width or diameter of theproximal end 36 of the suture needle and has an end 35 extending from adistal portion and having a reduced diameter to be received in the bore39 in a manner to produce a smooth profile to facilitate suturing. Asshown in FIG. 3, a preferred manner of forming the suture device 30 isby molding the suture needle 32 with the end of the suture material 34positioned in the mold such that the suture needle is formedsimultaneously with attachment of the suture material. The mold has twoparts 40 and 42 with recesses 44 and 46 therein having the shape ofsuture needle 32, and an inlet channel 48 is provided for injection of abioabsorbable material under pressure. Channels 50 and 52 are formed inmold parts 40 and 42 to accommodate suture material 34 and areessentially extensions of recesses 44 and 46 such that, during injectionmolding of the suture needle 32, the end of the suture material 34 iscaptured and securely attached to the proximal end 36 of the sutureneedle. The end of the suture material can extend as far into themolding recesses as required to produce a secure attachment. In formingthe suture needle 32, the plastic characteristics of the bioabsorbablematerial can be used to great advantage by controlling the flexibilityor rigidity of the suture needle to facilitate use in particularsurgical procedures. To this end, channels 48a and 48b can be positionedin mold parts 40 and 42 such that bioabsorbable materials with varyingcharacteristics can be injected to create a suture needle having aspecifically designed flexibility profile. For example, the portionadjacent sharp needle point 38 is preferably rigid, that is the portiondistally of channel 48b, while a central portion between channels 48aand 48b can be flexible or rigid while the proximal portion betweenchannels 48a and 48 can be flexible or rigid.

While it is preferred to mold the suture needle simultaneously withattaching the suture material since manufacture of the suture device isfacilitated and made less expensive by accomplishing two manufacturingprocesses in a single step, the end of the suture material can also beattached to the proximal end 36 by various mechanical means such as bythreading the bore 39a and the end 35a, as shown in FIG. 4, or providinga spherical recess 39b in proximal end 36b which is slit to expand toreceive a ball-shaped end 35b on suture material 34b having two lengthsas shown in FIG. 5. Additionally, the end of the suture material can besecured to the suture needle with the use of adhesives and/or heattreating or ultrasonic welding. Since the suture needle is made ofbioabsorbable material, bore 39 can have any length desired therebyallowing more secure attachment of the suture material thereto. Thesuture material could also be secured in the bore of the suture needleby anchoring or staking; however, it is preferable to take advantage ofthe plastic characteristics of the bioabsorbable material of the sutureneedle as well as the plastic characteristics of the suture material,when made of bioabsorbable material, in that the end of the suturematerial can be formed in any suitable manner with protrusions to bereceived in the bore or recess in the proximal end of the suture needlewith the latter having a configuration to lock the end therein.

The suture device 30 is used in a manner similar to conventionalsuturing, it being appreciated that, when used in endoscopic procedures,the suture needle 32 will be held by a conventional needle holder tocause the suture needle to penetrate through the tissue in a manner tothread the suture material in the tissue to approximate the edges of thetissue as desired. The suture needle 32 is severed from the suturematerial 34 after the suturing procedure is completed; and, should thesuture needle be dropped and lost prior to removal through the portal,open surgery is not required to find and remove the suture needle sinceit is made of bioabsorbable material and can be absorbed by the body.Accordingly, the suture needle 32 can be left in the body after suturingdue to inadvertence. Furthermore, since the suture needle is made ofbioabsorbable material, the suture needle can be intentionally lodged inthe tissue after suturing to additionally approximate and hold thetissue together. Accordingly, by making the suture needle ofbioabsorbable material many unexpected advantages are obtained includingfacilitating manufacture of the suture needle to particularspecifications as to rigidity and configuration, facilitating attachmentof a length of suture material thereto, allowing endoscopic proceduresto be performed with less apprehension relating to inadvertent loss ofthe suture needle and allowing the suture needle to be used toadditionally secure the tissue.

Another embodiment of a suture device according to the present inventionis illustrated in FIGS. 6 and 7 wherein a suture device 52 is formed ofa suture needle 54 and a length of suture material 56 preferably made offlexible bioabsorbable material. The suture needle 54 is formed ofbioabsorbable material to have a desired rigidity therealong asdescribed above; and, while a straight configuration is illustrated, thesuture needle can have any desired configuration corresponding tocommonly used suture needles such as the configurations shown in FIGS.1, 4 and 5. The suture needle 54 has a hollow proximal end 58 forming abore or recess 60 therein, and angled perforations or holes 62 extendthrough the wall surrounding the bore. The end of the suture material 56has angled, whisker-like filaments 64 extending rearwardly therefromhaving a size to be received in the holes 62 in the suture needle, theholes 62 similarly extending rearwardly from the inner surface to theouter surface toward the proximal end of the suture needle. To securethe suture material 56 to the suture needle 54, the end of the suturematerial is simply forced into the recess 60 until the end of the recessis reached; and, thereafter, the suture material is pulled rearwardly oraway from the suture needle causing the whisker-like filaments 64 topass through the holes 62 providing a secure attachment. As shown inFIG. 7, the whisker-like filaments 64 may extend beyond the outersurface of the suture needle; however, the whiskers are angledproximally away from the sharp tip at the distal end of the sutureneedle thereby not interfering with smooth suturing. Of course, thefilaments 64 can have a length less than the length of the holes 62 soas not to extend externally of the suture needle. The suture device 52is used in a similar fashion as the suture device 30.

The bore or recess 60 can extend along the length of the suture needle54 as shown at 61 in dashed lines to form a lumen or chamber such thatvarious local and/or systematic drugs can be stored in the lumens to bedispensed via the holes to the suture site. Such drugs include, forexample, insulin, antitumor agents, antibiotics, contraceptive agentsand the like. That is, by making the suture needles hollow with holesextending through the walls communicating with the lumen or chamber,drugs can be efficaciously applied to the suture site during suturing,and the lumen or chamber can be filled with a drug to be dispensed viathe opening in the proximal end 58 and sealed in the suture needle byattachment of the suture material which does not extend the length ofthe lumen.

Another embodiment of a suture device according to the present inventionis illustrated in FIG. 8 wherein a suture device 66 is formed of asuture needle 68 made of bioabsorbable material to have a desiredrigidity therealong as described above and having any desired curved orstraight configuration commonly used for suture needles with an eye 70formed in a proximal end 72 thereof. A length of suture material 74,preferably made of flexible, elastic or stretchable bioabsorbablematerial, is attached to the suture needle 68 by passing the suturematerial through the eye 70, folding it back upon itself, slipping aring or ring-like member 76, preferably made of bioabsorbable material,over the adjacent lengths of the suture material and securing the endsof the lengths of suture material together at an enlarged proximal endmember 77, for example, by fusing or welding. The enlarged proximal endmember 77 has a tapered locking neck 78 extending distally therefromwith protrusions thereon, such as proximally angled barbs, such that thelocking neck can be received in the ring 76 in locking engagement.

In use, suturing is accomplished with the suture needle 68 in normalfashion with a double filament of the suture material pulled through thetissue, as shown in FIG. 9; and, the suture needle 68 is passed througha contractible loop or passage 79 defined by the adjacent lengths ofsuture material, the ring 76 and the enlarged proximal end member 77.Accordingly, the suture material 74 can be pulled tight until the ring76 and the stretchable suture material proximal end member 77 abut thetissue with the desired tension, the neck 78 passing through the ring tolock the suture material in place and function similar to a conventionalsuture knot. After the suture material has been clamped between theproximal end member 77 and the ring 76 by the locking interactiontherebetween, the suture material can be severed as shown at the dashedline C and the suture needle removed or the suture needle can be lodgedin the tissue. If desired, an opening can be formed in the proximal end72 of the suture needle to allow insertion of the length of suturematerial therein, and the suture material can be twisted to assureattachment of the suture material to the suture needle.

Another embodiment of a suture device according to the present inventionis illustrated in FIGS. 10 and 11 wherein a suture device 80 is formedof a suture needle 81 made of bioabsorbable material to have a desiredrigidity therealong as described above and having any desired curved orstraight configuration commonly used for suture needles, the sutureneedle having a proximal end 82 formed with an arcuate channel 83therein, circular in cross-section, extending from a side entrance 84 toan end position 86 aligned with the longitudinal axis of the sutureneedle. A mouth 88 communicates with the channel 83 to receive a reduceddiameter projection 89 at the distal end of a length of suture material90, preferably made of flexible, elastic or stretchable bioabsorbablematerial. A ball 92 is formed on the end of projection 89, and thelength of suture material has a proximal end 94 formed of an elasticloop 96 that can be stretched open, as shown in dash lines to define apassage 98 therethrough. The suture material 90 is attached to thesuture needle 81 by inserting the ball 92 in the enlarged opening ofentrance 84 and moving the ball along channel 83 to the end position 86,the projection 89 passing through mouth 88. The suture device 80 is usedin a manner similar to that described above with respect to suturedevice 66 in that, after the suture needle penetrates the tissue to pullthe suture material through the tissue, suture needle 81 is passedthrough the passage 98 in the proximal end which stretches toaccommodate the largest transverse dimension of the suture needle and,thus, acts like loop 79 allowing the suture material to be pulled tightuntil the proximal end abuts the tissue with desired tension on thesuture material. That is, the loop 96 contracts to clamp the length ofsuture material in the manner of a conventional suture knot, and thesuture needle 81 can either be removed or lodged in the tissue.

Various bioabsorbable or biodegradable materials can be used to make thesuture devices of the present invention with the composition determinedby the rigidity or flexibility required. Generally, the bioabsorbablematerials are thermoplastic polymers such as absorbable polymers andcopolymers of poly-dioxanne, lactide, glycolide and the like.Polyglycolic acid is disclosed in U.S. Pat. Nos. 3,463,158; 3,739,773and 3,772,420. Suitable polylactic acids are disclosed in U.S. Pat. No.3,636,956. Examples of absorbable polyesters are shown in U.S. Pat. Nos.3,225,766 and 3,883,901. Absorbable cellulose glycolic acid ethers areshown in U.S. Pat. No. 2,764,159. Examples of suitable esters ofalpha-cyanoacrylic acid are found in U.S. Pat. Nos. 3,527,841, 3,564,078and 3,759,264. The variable rigidity of the suture needles can beobtained by changing the bioabsorbable material composition in portionsof the suture needles or by coating portions of the suture needles withbioabsorbable materials such as polycaprilactone.

The suture devices of the present invention can be any size from microto macro dependent upon the surgical procedures for which they aredesigned for use; and, it should be appreciated that, while the suturedevices of the present invention are particularly designed for use inendoscopic or closed procedures, they can also be used in openprocedures since the time required for suturing is substantially reducedresulting in a significant reduction in overall operating time. Thesuture needles can taper throughout their length to a sharp tip or canhave a constant diameter or cross section along their length with asharp conical, pyramidal or polygonal tip at the distal end. Theconfiguration of the suture needles in cross section can be varied inaccordance with surgical procedures to be performed including, forexample, circular, semi-circular, oval, lunar, rectangular, hexagonal,and polygonal solid or hollow configurations. Additionally, the outersurfaces of the suture needles can be grooved to facilitate penetration.The suture needles can be made in any conventional manner of workingwith plastic materials including molding, extrusion, stamping orcutting, and the suture needles and suture materials can be formedsimultaneously or separately.

The lengths of suture materials can be made of conventionalnon-bioabsorbable materials or of bioabsorbable materials and can beelastic or stretchable for specific surgical procedures. As shown inFIGS. 5 and 8, multiple lengths of suture materials can be attached tothe suture materials for specific surgical procedures and to effect aknot tying function.

Inasmuch as the present invention is subject to many variations,modifications and changes in detail, the above description of thepreferred embodiments is intended to be exemplary only and not limiting.

What is claimed:
 1. A suture device for joining bodily tissuecomprisinga suture needle having a sharp, tissue penetrating distal endand a proximal end; and suture material means having distal meansattached to said proximal end of said suture needle and proximal meansincluding passage means for passage of said cuture needle therethrough,said passage means being contractible for clamping a portion of saidsuture material means therein after said suture needle has passedtherethrough whereby said suture mateial means is controllably held inplace in the tissue after suturing.
 2. A suture device as recited inclaim 1 wherein said suture material means includes first and secondlengths of suture material having proximal ends and said passage meansincludes an end member connected with said proximal ends of said firstand second lengths of suture material and a ring-like member surroundingsaid first and second lengths of suture material and movablelongitudinally therealong to define a loop for passage of said sutureneedle therethrough between said end member, said ring-like member andsaid first and second lengths of said suture material.
 3. A suturedevice as recited in claim 2 and further comprising means for lockingsaid end member in engagement with said ring-like member.
 4. A suturedevice as recited in claim 3 wherein said suture material means is madeof bioabsorbable material.
 5. A suture device as recited in claim 3wherein said suture needle is made of bioabsorbable material.
 6. Asuture device as recited in claim 1 wherein said passage means is madeof a loop of elastic material stretchable for passage of said sutureneedle therethrough.
 7. A suture device as recited in claim 6 whereinsaid suture material means includes a single length of suture materialhaving a distal end connected with said loop of elastic material.
 8. Asuture device as recited in claim 7 wherein said suture material meansis made of bioabsorbable material.
 9. A suture device as recited inclaim 7 wherein said suture needle is made of bioabsorbable material.